Dataset Information

Maternal depression treatment in HIV (M-DEPTH): Study protocol for a cluster randomized controlled trial.

ABSTRACT: INTRODUCTION:Over one-third of human immunodeficiency virus (HIV)-infected pregnant women are clinically depressed, increasing the risk of mother-to-child transmission (MTCT) of HIV, as well as negative birth and child development outcomes. This study will evaluate the efficacy and cost-effectiveness of an evidence-based stepped care treatment model for perinatal depression (maternal depression treatment in HIV [M-DEPTH]) to improve adherence to prevention of MTCT care among HIV+ women in Uganda. METHODS:Eight antenatal care (ANC) clinics in Uganda will be randomized to implement either M-DEPTH (n=4) or usual care (n=4) for perinatal depression among 400 pregnant women (n=50 per clinic) between June 2019 and August 2022. At each site, women who screen positive for potential depression will be enrolled and followed for 18 months post-delivery, assessed in 6-month intervals: baseline, within 1 month of child delivery or pregnancy termination, and months 6, 12, and 18 following delivery. Primary outcomes include adherence to the prevention of mother-to-child transmission (PMTCT) care continuum-including maternal antiretroviral therapy and infant antiretrovial prophylaxis, and maternal virologic suppression; while secondary outcomes will include infant HIV status, post-natal maternal and child health outcomes, and depression treatment uptake and response. Repeated-measures multivariable regression analyses will be conducted to compare outcomes between M-DEPTH and usual care, using 2-tailed tests and an alpha cut-off of P <.05. Using a micro-costing approach, the research team will relate costs to outcomes, examining the incremental cost-effectiveness ration (ICER) of M-DEPTH relative to care as usual. DISCUSSION:This cluster randomized controlled trial will be one of the first to compare the effects of an evidence-based depression care model versus usual care on adherence to each step of the PMTCT care continuum. If determined to be efficacious and cost-effective, this study will provide a model for integrating depression care into ANC clinics and promoting adherence to PMTCT. TRIAL REGISTRATION:NIH Clinical Trial Registry NCT03892915 (clinicaltrials.gov).

SUBMITTER: Wagner GJ

PROVIDER: S-EPMC6635242 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Maternal depression treatment in HIV (M-DEPTH): Study protocol for a cluster randomized controlled trial.

Wagner Glenn J GJ McBain Ryan K RK Akena Dickens D Ngo Victoria V Nakigudde Janet J Nakku Juliet J Chemusto Harriet H Beyeza-Kashesya Jolly J Gwokyalya Violet V Faherty Laura J LJ Kyohangirwe Leticia L Nabitaka Linda Kisaakye LK Lukwata Hafsa H Linnemayr Sebastian S Ghosh-Dastidar Bonnie B Businge Juliet J Mukasa Barbara B Wanyenze Rhoda K RK

Medicine 20190701 27

<h4>Introduction</h4>Over one-third of human immunodeficiency virus (HIV)-infected pregnant women are clinically depressed, increasing the risk of mother-to-child transmission (MTCT) of HIV, as well as negative birth and child development outcomes. This study will evaluate the efficacy and cost-effectiveness of an evidence-based stepped care treatment model for perinatal depression (maternal depression treatment in HIV [M-DEPTH]) to improve adherence to prevention of MTCT care among HIV+ women i ...[more]

PMID: 31277180

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Project description:Despite 10 to% of persons living with HIV in sub-Saharan Africa having clinical depression, and the consequences of depression for key public health outcomes (HIV treatment adherence and condom use), depression treatment is rarely integrated into HIV care programs. Task-shifting, protocolized approaches to depression care have been used to overcome severe shortages of mental health specialists in developing countries, but not in sub-Saharan Africa and not with HIV clients. The aims of this trial are to evaluate the implementation outcomes and cost-effectiveness of a task-shifting, protocolized model of antidepressant care for HIV clinics in Uganda.INDEPTH-Uganda is a cluster randomized controlled trial that compares two task-shifting models of depression care--a protocolized model versus a model that relies on the clinical acumen of trained providers to provide depression care in ten public health HIV clinics in Uganda. In addition to data abstracted from routine data collection mechanisms and supervision logs, survey data will be collected from patient and provider longitudinal cohorts; at each site, a random sample of 150 medically stable patients who are depressed according to the PHQ-2 screening will be followed for 12 months, and providers involved in depression care implementation will be followed over 24 months. These data will be used to assess whether the two models differ on implementation outcomes (proportion screened, diagnosed, treated; provider fidelity to model of care), provider adoption of treatment care knowledge and practices, and depression alleviation. A cost-effectiveness analysis will be conducted to compare the relative use of resources by each model.If effective and resource-efficient, the task-shifting, protocolized model will provide an approach to building the capacity for sustainable integration of depression treatment in HIV care settings across sub-Saharan Africa and improving key public health outcomes.INDEPTH-Uganda has been registered with the National Institutes of Health sponsored clinical trials registry (3 February 2013) and has been assigned the identifier NCT02056106.

Project description:Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake.To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues.We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies.Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting "leaked" and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was difficult as the total number using LLTTF was less than 5% of all users and record linkage across websites was impossible. Confounding activity may have resulted in some increase in registrations in the control arm.Practitioners should consider online advertising to increase uptake of online therapy but need to check its additional value. A cluster RCT using location targeted adverts is feasible and this research design provides the best evidence of cost-effectiveness. Although our British pilot study is limited to online CBT for depression, a cluster RCT with similar design would be appropriate for other online treatments and countries and our recommendations may apply. They include ways of dealing with possible contamination (buffer zones and AdWords techniques), confounding factors (large number of clusters), advertising dose (in proportion to total number of users), record linkage (landing within target website), and length of study (4-6 months).clinicaltrials.gov (Registration No. NCT01469689); http://clinicaltrials.gov/ct2/show/NCT01469689 (Archived by WebCite at http://www.webcitation.org/6EtTthDOp).

Project description:BackgroundHIV testing is an essential gateway to HIV prevention and treatment thus controlling the HIV epidemic. More innovative interventions are needed to increase HIV testing among men who have sex with men (MSM) since their testing rate is still low. We proposed an online HIV test results exchange mechanism whereby the one without a certified online HIV report will be asked to test HIV for exchanging HIV report with others. The exchange mechanism is developed as an extension to the existing online HIV testing service system. Through the extended system, MSM can obtain certified online HIV reports and exchange their reports with friends via WeChat. This study aims to assess effectiveness of the exchange mechanism to increase the HIV testing rate among MSM.MethodsThis study will use a cluster randomized controlled trial (RCT) design. Participants are recruited based on the unit of individual social network, the sender and the receivers of the HIV report. An individual social network is composed of one sender (ego) and one or more receivers (alters). In this study, MSM in an HIV testing clinic are recruited as potential egos and forwarded online reports to their WeChat friends voluntarily. Friends are invited to participate by report links and become alters. Ego and alters serve as a cluster and are randomized to the group using the certified online HIV report with exchange mechanism (intervention group) or without exchange mechanism (control group). Alters are the intervention targeting participants. The primary outcome is HIV testing rate. Other outcomes are sexual transmitted infections, sexual behaviors, HIV testing norms, stigma, risk perception and HIV report delivery. The outcomes will be assessed at baseline and follow-up questionnaires. Analysis will be according to intention to treat approach and using mixed-effect models with networks and individuals as random effects.DiscussionThis is the first study to evaluate the effectiveness of an HIV test result exchange mechanism to increase the HIV testing among MSM. This assessment of the intervention will also provide scientific evidence on other potential effects. Findings from this study will yield insights for sustainability driven by communities' intrinsic motivation. Trail registration: ClinicalTrials.gov NCT03984136. Registered 12 June 2019.

Project description:UNLABELLED:Depression is common among people living with HIV, and it has consequences for both HIV prevention and treatment response, yet depression treatment is rarely integrated into HIV care in sub-Saharan Africa, partly due to the paucity of mental health professionals. We conducted a cluster randomized controlled trial of two task-shifting models to facilitating depression care delivered by medical providers: one that utilized a structured protocol, and one that relied on clinical acumen, in 10 HIV clinics in Uganda. Both models started with routine depression screening of all clients at triage using the 2-item Patient Health Questionnaire (PHQ-2), from which we enrolled 1252 clients (640 at structured protocol clinics, 612 at clinical acumen clinics) who had screened positive over 12 months. We compared the two models on (1) proportion of all client participants, and those clinically depressed (based on survey-administered 9-item PHQ-9>9), who received post-screening evaluation for depression using the PHQ-9; and (2) proportion of clinically depressed who were prescribed antidepressant therapy. Linear probability regression analyses were conducted using a wild cluster bootstrap to control for clustering; patient characteristics, clinic size and time fixed effects were included as covariates. Among all client participants, those in the structured protocol arm were far more likely to have received further evaluation by a medical provider using the PHQ-9 (84% vs. 49%; beta = .33; p = .01). Among the clinically depressed clients (n = 369), the advantage of the structured protocol model over clinical acumen was not statistically significant with regard to PHQ-9 depression evaluation (93% vs. 68%; beta = .21; p = .14) or prescription of antidepressants (69% vs. 58%; beta = .10; p = .50), in part because only 30% of clients who screened positive were clinically depressed. These findings reveal that in both models depression care practices were widely adopted by providers, and depression care reached most depressed clients. The structured protocol model is advantageous for ensuring that positively screened clients receive a depression evaluation, but the two models performed equally well in ensuring the treatment of depressed clients in the context of strong supervision support. TRIAL REGISTRATION:ClinicalTrials.gov NCT02056106.

Project description:The high rate of attrition along the care cascade of infection with human immunodeficiency virus (HIV) results in lost opportunities to provide timely antiretroviral therapy (ART) and to prevent unnecessarily high mortality. This study aims to assess the effectiveness of a structural intervention, the one-stop ("One4All") strategy that streamlines China's HIV care cascade with the intent to improve testing completeness, ART initiation, viral suppression, and mortality.A two-arm, cluster-randomized controlled trial was implemented in twelve county hospitals in Guangxi China to test the effectiveness of the One4All strategy (intervention arm) compared to the current standard of care (SOC; control arm). The twelve study hospitals were selected for homogeneity and allocated one-to-one to the intervention and control arms. All patients screening HIV positive in study hospitals were enrolled. Target study enrollment was 180 participants per arm, 30 participants per hospital. Basic demographic information was collected as well as HIV risk behavior and route of infection. In intervention hospitals, patients then went on to receive point-of-care CD4 testing and in-parallel viral load (VL) testing whereas patients in control hospitals progressed through the usual SOC cascade. The primary outcome measure was testing completeness within 30 days of positive initial HIV screening result. Testing completeness was defined as receipt of all tests, test results, and post-test counseling. The secondary outcome measure was ART initiation (receipt of first ART prescriptions) within 90 days of positive initial HIV screening result. Tertiary outcome measures were viral suppression (?200 copies/mL) and all-cause mortality at 12 months.We expect that this first-ever, cluster-randomized controlled trial of a bundle of interventions intended to streamline the HIV care cascade in China (the One4All strategy) will provide strong evidence for the benefit of accelerating diagnosis, thorough clinical assessment, and ART initiation via an optimized HIV care cascade. We furthermore anticipate that this evidence will be valuable to policymakers looking to elevate China's overall HIV/AIDS response to meet the UNAIDS 90-90-90 targets and the broader, global goal of eradication of the HIV/AIDS epidemic.ClinicalTrials.gov # NCT02084316 . (Registered on March 7, 2014).

Project description:BACKGROUND:Among countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability. OBJECTIVE:The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment. METHODS:We will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster-randomized controlled trial will be implemented in Lusaka, with six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing among the HIV-negative or unknown (HIV-/u) cohort, and retention in care along with viral load suppression will be evaluated in the HIV-positive (HIV+) cohort. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model. RESULTS:Interim results are expected in 2021, and the final results are expected in 2022. If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up. CONCLUSIONS:This integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services. TRIAL REGISTRATION:ClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/15314.

Project description:Depression and substance use are significant obstacles to effective HIV care. Using data derived from a randomized controlled trial of persons with HIV who are homeless or marginally housed, this study assesses the utility of antidepressant treatment among persons with HIV, depression, and active substance use. Participants were diagnosed with depressive disorders and randomly assigned to receive directly observed therapy with fluoxetine or a referral to community mental health treatment. Assessments, conducted at baseline and every 3 months over a 9-month period, included the Hamilton Rating Scale for Depression, the Beck Depression Inventory II, and self-report of alcohol, crack, cocaine, heroin, or methamphetamine use in the past 90 days. To investigate the effect of antidepressant treatment in the setting of active substance use, the authors fit mixed-effects linear regression models to estimate the effect of directly observed fluoxetine on depressive symptom severity after stratifying by any alcohol use or any illicit drug use. To investigate whether alcohol use or illicit drug use moderated the antidepressant treatment response, the authors examined the interaction terms. The effect of directly observed fluoxetine treatment on depression symptom severity was statistically significant irrespective of alcohol use status. When stratified by illicit drug use status, the effect of directly observed fluoxetine treatment on depression symptom severity was statistically significant only among persons who did not use illicit drugs. The interaction terms were not statistically significant. This study found a benefit of antidepressant treatment in persons with HIV, depression, and alcohol use. In addition, this study found no evidence that either alcohol use or illicit drug use moderates the antidepressant treatment response. Altogether, these findings support the use of antidepressant medication in this population. The public health impact of research in this area is significant given the known adverse effects of depression on HIV-related health outcomes. ClinicalTrials.gov Identifier: NCT00338767.

Project description:BackgroundPerinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are at an increased risk of depression; however, in Tanzania there is limited access to services provided by mental health professionals. This paper presents a protocol and baseline characteristics for a study evaluating a psychosocial support group intervention facilitated by lay community-based health workers (CBHWs) for perinatal women living with HIV and depression in Dar es Salaam.MethodsA cluster randomized controlled trial (RCT) is conducted comparing: 1) a psychosocial support group intervention; and 2) improved standard of mental health care. The study is implemented in reproductive and child health (RCH) centers providing PMTCT services. Baseline characteristics are presented by comparing sociodemographic characteristics and primary as well as secondary outcomes for the trial for intervention and control groups. The trial is registered under clinicaltrials.gov (NCT02039973).ResultsAmong 742 women enrolled, baseline characteristics were comparable for intervention and control groups, although more women in the control group had completed secondary school (25.2% versus 18.2%). Overall, findings suggest that the population is highly vulnerable with over 45% demonstrating food insecurity and 17% reporting intimate partner violence in the past 6 months.ConclusionsBaseline characteristics for the cluster RCT were comparable for intervention and control groups. The trial will examine the effectiveness of a psychosocial support group intervention for the treatment of depression among women living with HIV accessing PMTCT services. A reduction in the burden of depression in this vulnerable population has implications in the short-term for improved HIV-related outcomes and for potential long-term effects on child growth and development.Trial registrationThe trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered on January 20, 2014.

Dataset Information

Maternal depression treatment in HIV (M-DEPTH): Study protocol for a cluster randomized controlled trial.

Publications

Maternal depression treatment in HIV (M-DEPTH): Study protocol for a cluster randomized controlled trial.

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